drugset
drugset / Trial / NCT02750553

A Phase 1, Randomized, Placebo-controlled, Single & Multiple Dose Escalation Study to Investigate Safety, Pharmacokinetics, and Pharmacodynamics of SHR0534 in Healthy Chinese Volunteers

NCT02750553 ↗

Phase 1 Completed 51 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, placebo-controlled, single \& multiple dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be conducted with starting dose of 5 mg followed by dose escalation groups up to 100 mg. Healthy Chinese subjects will be randomized in each cohort to receive the study drug or placebo.

Timeline

Start
2015-01
Primary completion
2016-01
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject SHR0534 Unknown 5 mg Oral
Subject SHR0534 Unknown 10 mg Oral
Subject SHR0534 Unknown 25 mg Oral
Subject SHR0534 Unknown 50 mg Oral
Subject SHR0534 Unknown 100 mg Oral

Indications

No indication recorded.